Kornimate/medical-research-clean huggingface dataset:
a clinical study to determine if beta glucan reduces the incidence, duration or severity of urtis among skiers

Conditions: Upper Respiratory Tract Infections; Mental Stress

Summary: this study is designed to determine if a dieatary supplement containing beta-glucan can reduce the incidence, severity and duration of upper respiratory tract infections among a group of highly trained athletes

in this study, we hypothesize that consumption of 200 mg beta-glucan per day will lessen the frequency, duration and severity of urti symptoms in a population of elite, internationally competitive skiers over a 45-day period. in order to complete this objective, we will utilize the wisconsin upper respiratory symptom survey-24 (wurss-24) to monitor and quantify the incidence, duration and severity of urti symptoms. a secondary objective is to determine if beta-glucan supplementation reduces or mitigates early indictors of athlete-specific stress. this objective will be assessed using the athlete psychological strain questionnaire (apsq), a 10-question patient-reported outcome tool used to evaluate athlete-specific psychological stress. this will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 6-week period. 50-60 healthy subjects will be recruited and randomized in a 1:1 ratio to either of two interventions: 1. placebo: daily consumption of the placebo tablet 2. treatment: daily consumption of the supplement (treatment) tablet in addition, subjects will complete the wurss-24 survey daily, and the apsq survey weekly.

Eligibility criteria:
inclusion criteria: * provide informed consent by signing the electronic information and consent form. * male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background * are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study * are fully able and willing to comply with the requirements of the study * are fully able and willing to keep scheduled appointments exclusion criteria: * females that are pregnant, attempting to become pregnant or are currently lactating/nursing a child. * individuals currently taking prescription medications that are known to be immunosuppressants (e.g. dexamethasone, tacrolimus, methotrexate) * individuals with gastrointestinal conditions (e.g., inflammatory bowel disease, crohn's disease, etc.) that may affect consumption of the treatment supplements. * individuals with clinically important renal, hepatic, cardiac pulmonary, pancreatic, neurologic or biliary disorders; insulin-dependent and orally controlled diabetics will also be excluded from the study. * individuals with a recent history of cancer other than non-melanoma skin cancer. * individual's that have trouble swallowing pills. * individuals that have participated as a subject in any other clinical study within 30 days of screening. * individuals with a history of alcohol abuse or other substance abuse within the previous 2 years. * individuals that currently use tobacco products including chewing tobacco and cigarettes.
a study to evaluate the safety and efficacy of enzalutamide in chemotherapy-naïve, symptomatic patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: the purpose of this study is to investigate radiographic progression-free survival (pfs) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.


Eligibility criteria:
inclusion criteria: * progressive prostate cancer while on androgen deprivation therapy * castrate testosterone level * maintenance of surgical or medical castration for duration of study * radiographically visible metastatic disease * symptomatic from prostate cancer * eastern cooperative oncology group (ecog) 0-2 * life expectancy \>=6 months exclusion criteria: * brain metastases or leptomeningeal disease * prior cytotoxic chemotherapy for prostate cancer * prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor * history of seizure or condition that may predispose to seizure * history of loss of consciousness or transient ischemic attack within 12 months * clinically significant cardiovascular disease

Keywords: mdv3100 prostate cancer enzalutamide
pharmacokinetic drug interaction between yh4808 and diclofenac

Conditions: Healthy

Summary: the objective of this study is to compare pharmacokinetics after single oral administration of yh4808 and diclofenac each separately versus coadministration of yh4808 and diclofenac in healthy male volunteers


Eligibility criteria:
inclusion criteria: * healthy male age 20 to 45 over 55kg with ideal body weight(ibw) * no clinically important abnormal physical findings at the screening examination * subject who has no congential, chronic disease and disease symptoms in medical examination result * subject who is judged to be eligible by principal inverstigator or sub-investigator according to various reasons includiong ther abnorminal test results(clinical laboratory test, 12-lead gcg etc) * ability to communicate well with the inverstigator and to comply with the requremetns of the entire study * willingness to give written informed consent(prior to any study-related procedures beinging performed) and to be able to adhere to the study restrictions and examination schedule exclusion criteria: * suject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder * subject who is hypersensitive to components contained in yh4808 or declofenac or related drug(ex. rebamipide, revaprazan, nsid etc) * medical history of gastrointestinal disease or acid restraining surgery, gastric/ esophagus surgery(excluding appendectomy, hernia surgery) * subject who has history of drug dependence or using that drug * subject who had taken usual dose of any prescription durgs within 14 days before the treatment or who had used usual dose of otc drugs within 7 days before the treatment * subject who participated in antoher clinical trial within 2 monthes before enrolling in this study * subject who donated whole blood within 2 months or component blood within 1 month before the treatment * subject who drank over 21unit/week(1 unit= 10g of alcohol) or were not able to refrain from drinking alcohol during study days * subject who stopped smoking within 3 months before the treatment or detected cotinine in urine test * subject with clinically significant observations considered as unsuitable based on medical judgment by the investigators

Keywords: safety/tolerability and pharmacokinetics/pharmacodynamics
the impact of electroencephalographic (eeg) seizure treatment in neonatal encephalopathy

Conditions: Seizures; Encephalopathy

Summary: this is a prospective, randomized, single-center pilot trial of term and near term (≥ 36 weeks gestation) infants with encephalopathy or seizures comparing a "eeg seizure treatment group" or esg with a "clinical seizure treatment group" or csg. the investigators hypothesize that the accurate detection and treatment of eeg seizures will decrease the seizure burden and improve outcomes in newborn infants with seizures and/or hypoxic-ischemic encephalopathy (hie).

this is a prospective, randomized, pilot trial of term and near term (≥ 36 weeks gestation) infants with encephalopathy or seizures comparing a "eeg seizure treatment group" or esg with a "clinical seizure treatment group" or csg. eligibility is based on clinical criteria for moderate/severe encephalopathy or seizures. we will recruit near term or term infants (≥ 36 weeks gestation) with a diagnosis of seizures or encephalopathy admitted to the neonatal intensive care unit (nicu) at st. louis children's hospital within the first 72 hours of life. infants will be randomized into an eeg seizure treatment group (esg) or a clinical seizure treatment group (csg) (n=20 in each group). patients in both groups will have eeg monitoring. while treating physicians will have access to eeg data in the esg, no eeg data in the csg will be available to the clinician for treatment of seizures. aed treatment will be initiated/escalated using stringent eeg seizure criteria (est) or clinical criteria (cst) with the goal being seizure cessation. the specific aed, dosage, and duration of treatment is standardized in both groups. monitoring will continue for a period of upto 96 hours in both arms. other than the anticonvulsant drugs, treatment thresholds and dosing schedules, treatment in both arms will be at the discretion of the bedside physician.all infants will undergo an assessment of neuromotor disability and neurodevelopmental evaluation at 18 to 24 months.

Eligibility criteria:
inclusion criteria: * term or near term infants ≥ 36 weeks gestation admitted to the neonatal intensive care unit * ≤ 72 hours of age * screening for the "at risk" infant by the clinical team to include any one of the following: * apgar score \<5 at 5 min * cord blood or postnatal gas with ph \ -12 * need for respiratory support at 10 min of life * suspected or definite seizures * encephalopathy defined by recognition of altered neurological behavior * infants identified in the above screen will be examined by the research team and will be eligible if they satisfy at least one of the following: * moderate-severe neonatal encephalopathy (3 out of 6 criteria) * suspected or definite neonatal seizures exclusion criteria: * infants \< 36 weeks gestation * \> 72 hours of age * infants with congenital anomalies of the central nervous system * moribund infants for whom no further aggressive treatment is planned * metabolic disorders or documented cns infection * neuro-muscular blockade

Keywords: neonatal seizures neonatal encephalopathy
investigating the impact of indocyanine green titration on fluorescent intensity in free flap : an exploration of alternative indicators

Conditions: Free Flap; Indocyanine Green; Microsurgery; Temperature Change, Body

Summary: this study is a randomized clinical trials that aim to determine the effect of indocyanine green (icg) titration dose on the intensity degree of icg fluorescence imaging results. in addition, this study will also determine the relationship of other indicators such as flap surface temperature, transcutaneous pressure of carbon dioxide (tcpco2), transcutaneous pressure of oxygen (tcpco2), hif - 1 alpha expression, and flap histopathology morphology to the intensity degree of icg fluorescence imaging results with titrated doses.

the icg contrast solution will be evaluated with near-infrared (nir) camera that being fixated 20 cm above the flap after the injection. the imaging result will be analyzed using imagej application to assess the grey value. the fluorescent intensity of icg will be compared with other tests. drop out criteria : * patients who are unable to complete the research procedure due to various condition, such as death * patients who experience complications or worsening, during and after surgery.

Eligibility criteria:
inclusion criteria: * free flap operation that being performed by researchers. * free flap must have a skin paddle located on the body skin area with intraoperative ischemic time of at least 60 minutes * free flap should be in a viable/vital condition judged from the clinical examination of the flap, which includes color, temperature, turgor, capillary refill time (crt), and skin prick test, immediately post surgery * body area that will be a flap-free donor area has no history of trauma or operation * patient with blood albumin value \>3 gr / dl * the patient/family sign the informed consent sheet stating willingness to become research sample exclusion criteria: * patients have increased sensitivity to iodine or icg * free flaps that being transported undergo trauma or damage due to external factors during treatment * patient with high urea and creatinine level * patient with high alanine transaminase (alt) and aspartate transaminase (ast) level * patients who receive injectable heparin treatment containing natrium disulfite preoperatively * patients who regularly take anti-seizure drugs, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium, phenobarbital, and phenylbutazone.
latanoprost versus fotil

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to compare the intraocular pressure effect and safety of latanoprost 0.005% given every evening versus ptfc given twice daily.


Eligibility criteria:
inclusion criteria: * adults with primary open-angle or pigment dispersion glaucoma, or ocular hypertension * untreated intraocular pressure should be between 24-36 mm hg inclusive * visual acuity should be 5/50 or better in both eyes exclusion criteria: * presence of exfoliation syndrome or exfoliation glaucoma * contraindications to study medications * any anticipated change in systemic hypotensive therapy
mindfulness and chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to see if mindfulness, a form of mental training, or listening to a book alters brain activation in response to raising your leg that may produce the feeling of pain. a technique called functional magnetic resonance imaging (fmri) allows scientists to determine which parts of the brain are active during a particular task. this study will provide new information about how mindfulness affects the brain.

to determine if mindfulness meditation-induced reductions in chronic low back pain (clbp) patients will be associated with greater anterior insula (ains), orbitofrontal cortex (ofc), subgenual anterior cingulate cortex (sgacc), and/or thalamic deactivation when compared to rest, the sham-mindfulness meditation and the book-listening control groups. one-hundred and twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness meditation (n=40) and book-listening-control (n=40). each participants will be administered noxious heat and the chronic low back pain evoking, straight leg raise test during fmri.

Eligibility criteria:
inclusion criteria are: * participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. existing medical records, per physician discretion and low back examinations will confirm diagnosis. this will be determined over the phone during the (pre) screening and at study session 1, and will not be contingent on mri. * participants must be between the ages of 18-65 years. * participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale. * participants must have experienced their radicular pain for at least 3 months duration. * participants must be right-handed. * participants must have no prior meditative experience exclusion criteria: * participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period. * participants must not have had back surgery within the last year before their enrollment into the study. * participants must not have had any other sensory or motor deficits that precludes participation in this study. * participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, a personal history of psychosis. * participants must not have metal implants including ferrous arterial stints or coils, spinal stimulators, pacemakers, or defibrillators, permanently implanted hearing aides, bullets, bbs, or pellets, retinal eye implants, infusion pump for insulin or other medicines, ferrous surgical clips, staples, metal sutures, orthopedic hardware above or including the shoulders, body piercings that cannot be removed. * participants must not be claustrophobic. * participants must not produce negative straight leg test (i.e. a test is considered positive when the person reports reproducible pain at 40 degrees of hip flexion or less). * participants must not be pregnant * participants must not be over 275 pounds

Keywords: mindfulness fmri pain low back radicular
efficacy and safety study of multiple doses of imab362 in patients with advanced gastroesophageal cancer

Conditions: Solid Tumors

Summary: imab362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. preclinically imab362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). the aim of this phase ii study is to establish efficacy and safety of multiple doses of imab362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.


Eligibility criteria:
inclusion criteria: * metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology * cldn18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry * at least 1 measurable site of disease according to recist criteria exclusion criteria: * less than 3 weeks since prior chemo-or radiation therapy * other concurrent anticancer therapies * concurrent anticoagulation with vitamin k antagonists * therapeutic doses of heparin (prophylactic doses accepted) * uncontrolled or severe illness
evaluation of accuracy of rapid tests for group a beta hemolytic streptococci in out-patients with sore throat

Conditions: Pharyngitis

Summary: the purpose of this study is to evaluate accuracy of rapid tests for group a beta hemolytic streptococci in patients who presented with sore throat at out patient department in siriraj hospital.

the patients who presented with sore throat at out patient department less than 5 days and age over 6 years old would be enrolled by the primary physicians and the consent forms will be completed by researcher. the throat swab would be performed by using sofia, quickvue rapid tests compare to the gold standard which is a throat swab culture to evaluate the accuracy of the rapid tests. the sample size for validation of sensitivity and specificity of rapid tests is 358 patients. the primary outcome is will be evaluated sensitivity and specificity of both rapid tests.

Eligibility criteria:
inclusion criteria: * patients who came with sore throat less than 5 days. exclusion criteria: * no
japan dose regimen study of azd1656 in japanese type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the effect on glucose control of 3 different azd1656 dosing regimens with placebo in japanese type 2 diabetes mellitus (t2dm) patients, as evaluated by the change in hba1c from baseline to the end of treatment at 4 months.


Eligibility criteria:
inclusion criteria: * women of non-childbearing potential. * provision of informed consent prior to any study specific procedures * naïve t2dm patients with hba1c ≥ 7.5% but ≤ 10% or t2dm patients treated with one or two oral anti-hyperglycaemic agent(s) with hba1c ≥ 7.5% but ≤ 9.5% at enrolment visit (visit1) exclusion criteria: * clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, hepatic disease and haematological disease. * the investigator(s) judged that the subject should not participate in the study according to screening test or medical history. * participation in another clinical trial and/or intake of another investigational drug within the last 30 days prior to enrolment visit

Keywords: type 2 diabetes mellitus japanese phase 2 azd1656 efficacy dose regimen pharmacokinetics
tailored post-surgical therapy in early stage nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: our hypothesis is that patients receiving therapy based on their baseline tumor ercc1 levels and egfr mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. using this selective approach, patients with stage ii and iiia non n2 nsclc in the genotypic arm with low ercc1 levels will receive cisplatin plus pemetrexed, and those with high ercc1 levels will not receive cisplatin-based chemotherapy. if they harbor egrf mutations they will be treated with erlotinib. the study will be restricted to non-squamous nsclc for two mains reasons. first, this will enrich the egfr mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous nsclc.


Eligibility criteria:
inclusion criteria: * nsclc that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted) * surgically resected nsclc with pathological stage ii or stage iiia non-n2 (tnm classification 2008) * performance status (ps) = 0 or 1 * 18 years \<= age \< 70 years * signed inform consent exclusion criteria: * squamous cell carcinoma * previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix * inadequate renal or cardiac functions * pregnant women * any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, nyha class iii or iv congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis

Keywords: chemotherapy, adjuvant